The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for end-to-end Phase 1 study execution
Job Summary
The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for end-to-end Phase 1 study execution.
Responsibilities include protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating PK/PD attachments for clinical study reports and regulatory submission documents.
The role requires collaboration with other departments to facilitate on-time deliverables and adherence to SOPs and regulatory requirements.
Matching Summary
The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for end-to-end Phase 1 study execution.
Skills & Requirements
Must-have
Clinical Pharmacokinetics (PK) analysis
Protocol development
PK/PD data analysis
Phoenix WinNonlin experience
Data handling skills
Regulatory submission documents
Nice-to-have
Work effectively in matrix environment
Mentor junior scientists
Familiar with regulatory guidelines
General understanding of drug development
Key Requirements
Minimum of 4 years of clinical experience
Bachelor’s degree or higher
Knowledge of PK, PD, and statistical principles
Working knowledge of database structures (e.g. SDTM, ADaM)